Cardiac Damage in Degenerative Mitral Regurgitation Treated With Transcatheter Mitral Edge-to-Edge Repair.

BACKGROUND: The extent of cardiac damage and its association with clinical outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation remains unclear. This study was aimed to investigate cardiac damage in patients with degenerative mitral regurgitation treated with TEER and its association with outcomes. METHODS: We analyzed patients with degenerative mitral regurgitation treated with TEER in the Optimized Catheter Valvular Intervention-Mitral registry, which is a prospective, multicenter observational data collection in Japan. The study subjects were classified according to the extent of cardiac damage at baseline: no extravalvular cardiac damage (stage 0), mild left ventricular or left atrial damage (stage 1), moderate left ventricular or left atrial damage (stage 2), or right heart damage (stage 3). Two-year mortality after TEER was compared using Kaplan-Meier analysis. RESULTS: Out of 579 study participants, 8 (1.4%) were classified as stage 0, 76 (13.1%) as stage 1, 319 (55.1%) as stage 2, and 176 (30.4%) as stage 3. Two-year survival was 100% in stage 0, 89.5% in stage 1, 78.9% in stage 2, and 75.3% in stage 3 (P=0.013). Compared with stage 0 to 1, stage 2 (hazard ratio, 3.34 [95% CI, 1.03-10.81]; P=0.044) and stage 3 (hazard ratio, 4.51 [95% CI, 1.37-14.85]; P=0.013) were associated with increased risk of 2-year mortality after TEER. Significant reductions in heart failure rehospitalization rate and New York Heart Association functional scale were observed following TEER (both, P<0.001), irrespective of the stage of cardiac damage. CONCLUSIONS: Advanced cardiac damage is associated with an increased risk of mortality in patients undergoing TEER for degenerative mitral regurgitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: UMIN000023653.

Predictive Factors of Cardiac Mortality Following TEER in Patients with Secondary Mitral Regurgitation.

Background: Transcatheter edge-to-edge mitral valve repair (TEER) has emerged as a viable approach to addressing substantial secondary mitral regurgitation. In the contemporary landscape where ultimate heart failure-specific therapies, such as cardiac replacement modalities, are available, prognosticating a high-risk cohort susceptible to early cardiac mortality post-TEER is pivotal for formulating an effective therapeutic regimen. Methods: Our study encompassed individuals with secondary mitral regurgitation and chronic heart failure enlisted in the multi-center (Optimized CathEter vAlvular iNtervention (OCEAN)-Mitral registry. We conducted an assessment of baseline variables associated with cardiac death within one year following TEER. Results: Amongst the 1517 patients (median age: 78 years, 899 males), 101 experienced cardiac mortality during the 1-year observation period after undergoing TEER. Notably, a history of heart failure-related admissions within the preceding year, utilization of intravenous inotropes, and elevated plasma B-type natriuretic peptide levels emerged as independent prognosticators for the primary outcome (p < 0.05 for all). Subsequently, we devised a novel risk-scoring system encompassing these variables, which significantly stratified the cumulative incidence of the 1-year primary outcome (16%, 8%, and 4%, p < 0.001). Conclusions: Our study culminated in the development of a new risk-scoring system aimed at predicting 1-year cardiac mortality post-TEER.

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.

Background: Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. Objectives: This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. Methods: The OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. Results: In total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). Conclusions: The OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653).

One-Year Outcomes and Their Relationship to Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair With MitraClip Device: Insights From the OCEAN-Mitral Registry.

Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge-to-edge repair in the large Asian-Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN-Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge-to-edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02). Conclusions The OCEAN-Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge-to-edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge-to-edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information https://upload.umin.ac.jp. Identifier: UMIN000023653.

Revisiting the Aortic Valve Calcium Score in Evaluating the Severity of Aortic Stenosis in Japanese Patients　- A Single-Center Study.

Background: In patients with aortic stenosis (AS), measurement of aortic valve calcification (AVC) using computed tomography (CT) is recommended in cases where echocardiographic measurements are inconclusive. However, sex-specific AVC thresholds proposed in the guidelines for predicting severe AS (women: 1,200 arbitrary units [AU]; men: 2,000 AU) are based on studies from Western countries. Methods and Results: We retrospectively included 512 Japanese patients with at least moderate AS who underwent transthoracic echocardiography and CT. AVC was quantified using the Agatston method. AVC was positively correlated with peak aortic jet velocity and mean transvalvular gradient (mPG), and negatively correlated with aortic valve area (AVA) and the AVA index (AVAi). In 257 patients with concordant AS grading (152 severe AS [AVAi ≤0.6 cm2/m2, mPG ≥40 mmHg], 105 moderate AS [AVAi >0.6 cm2/m2, mPG <40 mmHg]), receiver operating characteristic curve analysis of AVC predicting severe AS yielded an area under the curve of 0.91 (95% confidence interval [CI] 0.87-0.95; P<0.001) in women and 0.86 (95% CI 0.75-0.98; P<0.001) in men. The optimal thresholds (women: 1,379 AU; men: 1,802 AU) were close to those proposed in the guidelines. The diagnostic accuracy of the thresholds in the guidelines was similar to that of the optimal thresholds. Conclusions: The sex-specific AVC thresholds proposed in international guidelines can be applied to Japanese AS patients, yielding similar diagnostic accuracy as the optimal cut-off derived from the study patients.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.